Circulation
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Multicenter Study Clinical Trial
Implantable left ventricular assist device. Approaching an alternative for end-stage heart failure. Implantable LVAD Study Group.
The implantable left ventricular assist device (LVAD) was designed to provide circulatory support as an alternative to heart transplantation or to continued medical therapy of end-stage heart failure. Initial experience with the implantable LVAD used as a bridge to heart transplantation provides a clinical opportunity to study the function of the device and adaptation by the patient. ⋯ Bridge to transplant implantable LVAD experience indicates that hemodynamic improvement should be significant after insertion of the devices and that the risk of thromboembolic events with the HeartMate LVAD should be extremely low. Rehabilitation and quality of life should be markedly improved. Limitations of extrapolating this clinical experience to the permanent implantable LVAD include that these patients were hospitalized (permanent implants will be outpatients); the "vented-electric" HeartMate LVAD was not tested (it is a portable, battery-powered device), and true "chronic" LVAD support (> 1 year) was not tested, so questions regarding long-term device reliability and the chronic risk of infection are unknown.